FDA 510(k) Application Details - K132725

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K132725
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant JUVORA
TECHNOLOGY CENTRE
HILLHOUSE INTERNATIONAL
THORNTON-CLEVELEYS, LANCASHIRE FY5 4QD GB
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Contact SELINA SHAW
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 08/30/2013
Decision Date 01/23/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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